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Compares treatment options for Non-Small Cell Lung Cancer
Official title A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery
ClinicalTrials.gov ID: NCT07182682
What this study is testing
What is sunvozertinib?
sunvozertinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To assess the efficacy and safety of sunvozertinib versus placebo as adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) or P-loop and αC-helix compression (PACC) mutations, who have had radical surgery, regardless of adjuvant chemotherapy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide a signed and dated informed consent form (ICF) prior to any study specific procedures, sampling, and analyses.
- Aged at least 18 years old at the time of ICF signature.
- Complete resection (R0) of the primary tumor and histologically confirmed diagnosis of NSCLC (participants with tumor histology indicative of...
- Complete surgical resection of the primary NSCLC is mandatory. All gross lesions must be completely resected to achieve microscopically negative...
- Acceptable surgery type: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.
You likely can't join if
- Concurrent EGFR sensitizing mutations (L858R and/or exon 19 deletion) or other driver gene variations with available standard therapies (e.g., ALK...
- Participants who have had only segmentectomies or wedge resections.
- Participants who have received any preoperative or postoperative radiotherapy for NSCLC, or who plan to have radiotherapy during the study.
- Participants who have received any EGFR TKIs as (neo)adjuvant therapy for NSCLC or have known pathological complete response from previous...
- Participants who are receiving (or unable to stop) medications or herbs known to be strong CYP3A inducers within 2 weeks prior to randomization.
- Previous history of interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring steroid therapy, any evidence of clinically...
See the full eligibility criteria
Who can join
- Provide a signed and dated informed consent form (ICF) prior to any study specific procedures, sampling, and analyses.
- Aged at least 18 years old at the time of ICF signature.
- Complete resection (R0) of the primary tumor and histologically confirmed diagnosis of NSCLC (participants with tumor histology indicative of neuroendocrine carcinoma, sarcomatoid carcinoma, or small cell lung cancer...
- Complete surgical resection of the primary NSCLC is mandatory. All gross lesions must be completely resected to achieve microscopically negative margins. Hilar and mediastinal lymph node dissection should be performed...
- Acceptable surgery type: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy.
- Acceptable surgery approach: thoracotomy or thoracoscopic surgery.
- Participants must have NSCLC classified post-operatively as stage IB, II, or IIIA according to the AJCC TNM staging 9.0th edition.
- Have documented EGFR exon20ins (Cohort 1) or EGFR PACC mutations (Cohort 2) from a local Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (or equivalent).
- Common EGFR PACC mutations include, but not limited to, L718Q, G719X, S768I, L747P/S, V769L, E709\_T710delinsD, L792H, and T854I.
- Participants must provide sufficient tumor tissue samples for confirmation of EGFR mutations by the sponsor designated central laboratory.
- ECOG performance status is 0 or 1.
- Participants must recover from prior lung surgery and systemic therapy (e.g., neoadjuvant therapy and/or adjuvant chemotherapy) without Grade 1 or higher AEs (except alopecia of any grade and ≤ Grade 2...
- Participants who have not previously received adjuvant chemotherapy should be assigned by chance as early as 4 weeks and within 10 weeks after the radical surgery.
- Participants who have previously received adjuvant chemotherapy can be assigned by chance within 2 - 10 weeks of completion of adjuvant chemotherapy with a maximum interval of no more than 26 weeks from surgery to...
- Adequate bone marrow reservation or organ functions within 7 days prior to randomization.
- Male participants with female partners of child-bearing potential should use barrier contraceptives (e.g., by use of condoms), during their participation in this study and for 6 months following the last dose of the...
- Female participants of child-bearing potential should use reliable contraceptives from the time of screening until 2 months after discontinuation of study drug. Female participants should not be breast feeding and must...
- Post-menopausal defined as aged at least 50 years old and amenorrhea for at least 12 months following cessation of all exogenous hormonal treatment.
- Women under 50 years old would be considered postmenopausal if they have been amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating...
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
What rules you out
- Concurrent EGFR sensitizing mutations (L858R and/or exon 19 deletion) or other driver gene variations with available standard therapies (e.g., ALK positive).
- Participants who have had only segmentectomies or wedge resections.
- Participants who have received any preoperative or postoperative radiotherapy for NSCLC, or who plan to have radiotherapy during the study.
- Participants who have received any EGFR TKIs as (neo)adjuvant therapy for NSCLC or have known pathological complete response from previous neoadjuvant therapy.
- Participants who are receiving (or unable to stop) medications or herbs known to be strong CYP3A inducers within 2 weeks prior to randomization.
- Previous history of interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring steroid therapy, any evidence of clinically active ILD, or immunotherapy induced pneumonitis.
- Any serious or uncontrolled systemic disease requiring treatment, including uncontrolled hypertension, diabetes, chronic heart failure and active bleeding disorders (such as hemophilia, von Willebrand disease), etc...
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \> 470 msec on 3 ECGs at screening
- Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval \> 250 msec.
- Any factors that increase the risk of QTc prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old in first degree...
- Prior history of atrial fibrillation within 6 months of the first dose of study drug, except for those related to drug treatment and recovered.
- Participants with a history of any malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ or other solid tumors with \>5 years since completion of anti-cancer therapy and no evidence of...
- Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous major bowel resection that may preclude adequate absorption of sunvozertinib.
- Hypersensitivity to sunvozertinib, excipients of sunvozertinib, or drugs of similar chemical structure or same class.
- Involvement in the design, planning or conduct of this study (applicable to Dizal staff or study site staff).
- Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions or requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Fuzhou, China
- Guangzhou, China
- Hangzhou, China
- Harbin, China
- Hefei, China
- Jinan, China
- Kunming, China
- Nanchang, China
- Nanjing, China
- Nanning, China
- Shanghai, China
- Shenyang, China
- Taiyuan, China
- Taizhou, China
- Tianjin, China
- Wuhan, China
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changchun, China; Changsha, China; Chengdu, China; Fuzhou, China; Guangzhou, China and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.